Safety Trial Of CTX Cells In Patients With Lower Limb Ischaemia
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|ClinicalTrials.gov Identifier: NCT01916369|
Recruitment Status : Completed
First Posted : August 5, 2013
Last Update Posted : January 31, 2018
|Condition or disease||Intervention/treatment||Phase|
|Peripheral Arterial Disease||Biological: CTX DP||Phase 1|
Design: The trial is a multi-centre open label, non-comparative, ascending dose safety study, using CTX cells to treat patients with lower limb ischaemia, with follow-up over 12 months.
Pre-treatment selection of patients: Men and women, aged >50 years with peripheral arterial occlusive disease (Fontaine Stage II through IV) of one leg or both, unsuitable for surgical re-vascularisation, an ankle/brachial pressure index (ABPI) of <0.9 or a toe/brachial index of <0.7. Women must be surgically sterile or more than 2 years past their last menstrual period and test negative for pregnancy.
Treatment: One patient will be treated at one time with a single dose of CTX cells. Three ascending doses (20, 50 or 80 million cells), allocated sequentially, will be tested in 9-18 patients (3 dose cohorts of 3-6 patients. All trial patients will receive 10 intramuscular injections of CTX DP into the gastrocnemius muscle of their ischaemic leg on a single occasion. In the event that both legs have peripheral arterial disease, the injections will be administered to the leg determined by the Investigator to have the more advanced/severe disease provided that leg has not already had surgical amputation of toes or above.
A minimum interval of 28 days will be observed between dosing the first and second patient and 7 days between dosing subsequent patients in a given cohort in order to assess the safety and tolerability of CTX DP at that dose. A further 3 patients may be added to any cohort (to a maximum of 18 of total treated patients) at the discretion of the Data Safety Monitoring Board (DSMB) if required to further clarify the safety profile). A minimum interval of 28 days will be observed between dosing the first and second patient and 7 days between dosing subsequent patients in a given cohort in order to assess the safety and tolerability of CTX DP at that dose.
Post-treatment follow-up: There will be 8 scheduled visits to the clinic for monitoring over the 12 month follow-up period.
End-points: The primary endpoint of the trial is safety, measured by numbers of relevant adverse events, health screening, physical examination (overall and of the treated limb), immunological response, amputation and concomitant medications in the first year after treatment.
Post-trial follow-up: Life-long annual follow-up to record any new cancer via national cancer registry or similar system or by Investigator or family practitioner (as permitted by competent authorities, ethics committees and informed consent).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Ascending Dose Safety Study Of Intramuscular CTX0E03 In Patients With Lower Limb Ischaemia|
|Study Start Date :||April 2014|
|Actual Primary Completion Date :||January 16, 2018|
|Actual Study Completion Date :||January 16, 2018|
Experimental: CTX DP
Human neural stem cell product, single dose administered once only, increasing doses
Biological: CTX DP
Single dose treatment consisting of 10 injections (20, 50 or 80 million cells) into the gastrocnemius muscle near to the damaged area
Other Name: CTX0E03
- incidence of adverse events [ Time Frame: 12 months ]Monitoring of medical history, general physical examination, physical examination of the ipsilateral leg (inflammation, infection, swelling, tenderness, ulceration, gangrene), temperature, pulse rate and rhythm, ECG, blood pressure, full blood count, liver function tests, serum urea and electrolytes, creatine phosphokinase(muscle isoform), immunological response to CTX, amputation and concomitant medication.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01916369
|Dundee, Scotland, United Kingdom, DD1 4HN|
|Principal Investigator:||Jill JF Belch, MBChB||Ninewells Hospital Dundee|